Back to resultsPain Management Using Guided Imagery for Adolescents Post-spinal Fusion
Primary Purpose
Pain, Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Guided imagery intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Scoliosis, Rehabilitation, Cognitive-behavioral interventions, Adolescents
Eligibility Criteria
Inclusion Criteria:
- Aged between 11 and 20 years old
- Have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis
- Able to write and understand French
- Requires a computer or DVD player at home.
Exclusion Criteria:
- Diagnosed with a moderate cognitive deficit or severe mental retardation
Sites / Locations
- CHU Ste-Justine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Guided imagery
Arm Description
Outcomes
Primary Outcome Measures
Level of pain intensity
Pain was measured before the patients left the hospital on their 7th postoperative day (T-1, time of discharge from hospital). It was measured again at two week post-discharge (T-2) and also at one month post-discharge (T-3) on their visit to the orthopedic clinic. Our primary outcome was at T-2.
Secondary Outcome Measures
Level of anxiety
Anxiety was measured as baseline data on the pre-operative visit (24 hrs before surgery). It was also measured at two weeks post-discharge and at one month on the day of the visit to the orthopedic clinic.
Level of coping
Coping strategies of adolescents regarding their pain management were also measured pre-operatively (24 hrs before surgery), at two weeks and one month post-surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01663909
Brief Title
Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion
Official Title
The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain management a complex task. Several studies have found out that pharmacological interventions alone were not enough to provide optimal pain management for these patients. The investigators developed a DVD on guided imagery, customized for teenagers, to help them cope better with their pain. The investigators believe that this type of intervention combined with their usual analgesic medication will help them to control their pain and foster rehabilitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Scoliosis
Keywords
Pain, Scoliosis, Rehabilitation, Cognitive-behavioral interventions, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Title
Guided imagery
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Guided imagery intervention
Intervention Description
A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.
Primary Outcome Measure Information:
Title
Level of pain intensity
Description
Pain was measured before the patients left the hospital on their 7th postoperative day (T-1, time of discharge from hospital). It was measured again at two week post-discharge (T-2) and also at one month post-discharge (T-3) on their visit to the orthopedic clinic. Our primary outcome was at T-2.
Time Frame
Level of pain intensity at two weeks after the surgery
Secondary Outcome Measure Information:
Title
Level of anxiety
Description
Anxiety was measured as baseline data on the pre-operative visit (24 hrs before surgery). It was also measured at two weeks post-discharge and at one month on the day of the visit to the orthopedic clinic.
Time Frame
Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery
Title
Level of coping
Description
Coping strategies of adolescents regarding their pain management were also measured pre-operatively (24 hrs before surgery), at two weeks and one month post-surgery.
Time Frame
Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 11 and 20 years old
Have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis
Able to write and understand French
Requires a computer or DVD player at home.
Exclusion Criteria:
Diagnosed with a moderate cognitive deficit or severe mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Le May, RN, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
Facility Information:
Facility Name
CHU Ste-Justine Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion
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